Regulatory Publisher

Green Key Resources
Gaithersburg, MD
Aug 11, 2017
Jobs Outside Higher Education
Publishers & Presses, Research & Development
Institution Type
Outside Academe

Job Description


Under direct supervision the incumbent is responsible for assisting the Scientific Affairs Department with performing Publishing and formatting of US and Ex-US regulatory submission documents to ensure that they follow clients style and publishing guidelines.

  • Providing support and technical assistance for publishing and formatting of regulatory submission documents
  • Working in Adobe Acrobat using advanced features such as OCR, File Optimization and bookmark and link auditor
  • Coordinate with Submissions Team and authors to ensure submission documents are formatted processed and submitted on-time
  • Compiling and publishing eCTD sequences using an eCTD building/compilation software as needed
  • Performing detailed QC of eCTD and paper submissions processed internally and by external vendors
  • Providing support as needed to Regulatory Affairs/Operations personnel
  • Administering routine file management and maintaining submission logs and files

  • Performing routine submission publishing activities associated with electronic and hard copy submissions
  • Work closely with cross-functional team members and Submissions Team to compile documents needed for a submission, manage version control, and track documents for assigned projects
  • Process paper submissions for INDs, NDAs, BLAs, and ODAs per FDA/ICH guidelines and FDA's current thinking stated at conferences and submit to the Agency
  • Responsible for formatting Word documents by applying appropriate styles/templates
  • Formatting PDF documents using Acrobat and ISI Toolbox that include aspects of publishing activities involving bookmarking, hyper linking, and other requirements to ensure compliant electronic documents
  • Coordinate with contracted publishing vendors for outsourced electronic submissions and maintaining submission logs
  • QC eCTD and paper submission published outputs for all required submission per Agency requirements
  • Support Pharmacovigillance with submissions sent through the electronic system gateway (ESG)
  • Manage the tracking of submission documents between authors and the Submissions Team (both internal and external vendors); duties include updating document trackers, uploading to and downloading from portals, and maintaining portal folders with support of the Submissions Team.
  • Support the Submissions Team for archiving Regulatory Agency documents, including submissions, letters, and contact reports, in the Document Management System and on the internal drive
  • Organize and maintain folder structures in the document management system, internal drive, and client portals

  • Bachelor's Degree or country equivalent with 5 years of regulatory/regulatory operations experience preferably within a healthcare environment. Scientific or related discipline would be an advantage.
  • Expert working knowledge with submission publishing concepts, guideline and industry Best practices
  • Experience and knowledge in CTD (paper and electronic) granularity and proficiency in word processing of authored documents.
  • Knowledge of nonclinical, clinical, and CMC submission documents
  • Expert working knowledge of MS Word Templates, word processing, styles and their function and use.
  • Proficiency in MS Office applications, Adobe Acrobat plug-ins such as ISI Toolbox and pre-publishing activities (including bookmarking, linking, and editing); submission publishing experience for both paper and electronic submissions is a must
  • Ability to manipulate text with the use of MS Word Styles and formatting techniques.
  • Strong knowledge of FDA and ICH regulations and guidelines related to paper and eCTD submissions
  • Attention to detail and ability to support multiple projects
  • Technical system skills (e.g. strong familiarity with DMS, file organization, ISI Toolbox, Adobe Acrobat, MS Word Templates)
  • Excellent oral and written communication skills
  • Must demonstrate excellent planning and organizational skills and an ability to generate creative solutions for complex problems
  • Ability to work independently and in a team environment

Company Description
Green Key Resources is a premier executive recruitment firm specializing in permanent placement, contract consulting, temp-to-hire and temporary staffing within the following specialty areas: accounting-finance, healthcare nursing & allied health, pharmaceutical, financial service operations, alternative asset management, information technology, office/legal support and human resources.

Our expertise, innovation, and commitment to our candidates and clients have made Green Key an award-winning company with a proven record of success. We know the steps it takes to build a happier future, and we're here to guide you on your way.

Gaithersburg, MD


Thu, 10 Aug 2017 10:51:54 PDT